–Pilot study confirms feasibility, but clinical value for healthy-seeming people is not obvious Whole genome sequencing (WGS)may one day play an important role in routine medical practice. But the results of a small study suggest that WGS, though perhaps promising, is certainly not ready for prime time. The price of WGS has dropped spectacularly in…
No One Knows What’s Actually In Red Yeast Rice Supplements
–Despite tighter FDA rules red yeast supplements may not contain the active ingredient– or far too much of it. A new study offers fresh evidence that it is impossible for consumers (or their doctors) to know what they are getting when they buy dietary supplements. Dietary supplements have long been, at best, loosely regulated in…
My Beef With The AHA’s Saturated Fat Recommendations
–We shouldn’t forget the unintended consequences of dietary recommendations. The American Heart Association’s position on saturated fat pretends to be science-based but is not, writes Gary Taubes, in a brilliant and wildly popular guest post published here on CardioBrief late last week. The AHA’s statement, which recommends that saturated fats be replaced with polyunsaturated…
Guest Post: Vegetable Oils, (Francis) Bacon, Bing Crosby, And The American Heart Association
–Gary Taubes responds to the AHA presidential advisory on dietary fats. Editor’s note: I was planning to write about the American Heart Association’s new statement about dietary fats so I asked Gary Taubes for a brief quote. Taubes, of course, is an investigative science and health journalist who has written three major books (Good Calories,…
Serious Bleeding Risk With Aspirin Soars With Age
–Routine PPI use might cut the risk of major bleeds in people over 75. Older people who take aspirin to prevent a recurrent cardiovascular event should take a proton-pump inhibitor to lower their risk of serious bleeding complications, say the authors of a new study published in the Lancet. After a transient ischemic attack, ischemic…
Review Lends Modest Support To Chinese Traditional Medicine For CV Disease
–Tantalizing suggestion of benefit but evidence is weak and sparse. Traditional Chinese medicine (TCM) is used by hundreds of millions of Chinese people and increasing numbers of people in developed countries. A new state-of-the-art review published in the Journal of the American College of Cardiology suggests that some TCM products may be helpful in different…
Trustee For Zombie Lab Sues Thousands Of Doctors And Dozens Of Nonprofits
–The suits unveil the scope and sordid details of the massive kickback scheme. Thousands of doctors are being sued by the trustee representing the creditors of Health Diagnostic Laboratory (HDL), the bankrupt laboratory company. The trustee is demanding that the doctors repay thousands of dollars in illegal processing and handling (P&H) fees, a key part…
New Stroke Prevention Device May Not Prevent Strokes
–There’s no hard evidence the Sentinel Cerebral Protection System reduces stroke in TAVR. Here’s how to get a second generation medical product or add-on product approved: show that the original device isn’t nearly as safe and effective as believed back in, you know, the dark ages before the new product showed up. Until now proponents…
The Unintended Consequences Of Bicycle Helmets
(UPDATED) –We should encourage people to cycle, not scare them away. From personal experience I can attest that it is almost impossible, in the US at least, to have an intelligent conversation about bicycle helmets. The universal view is that you have to be crazy not to wear a helmet. Since I almost never wear…
Study Finds Alarming Increase In US Bicycle Accidents
–But doesn’t consider the public health benefits of cycling The problem: bicycle accidents in adults in the U.S. now cost more than $24 billion a year. The solution: more, not fewer, bikes! A new paper published in the journal Injury Prevention finds that the number and costs of bicycle accidents in the U.S. have risen…
Last Beats of the Failing Heart — Two Views
–Milton Packer and Richard Lehman compare perspectives, Part 3 Editor’s note: This is the third installment of an ongoing discussion about heart failure (HF) between Milton PackerMD, who has been leading major heart failure clinical trials for decades, and Richard Lehman, MA, BM, BCh, MRCGP, a retired U.K. GP who writes a blog for the…
Two NEJM Papers Spotlight Promising But Early New Cardio Drugs
Now that cardiologists and other doctors are comfortable talking about PCSK9 inhibitors they can start preparing to add a new mouthful of a therapeutic target to their vocabulary: angiopoietin-like-3 (ANGPTL3). Two papers published in the New England Journal of Medicine by industry researchers provide a snapshot of promising but still early research on two new drugs that target…
Should Everyone With Heart Failure Get Aggressive Treatment?
–A Conversation About Heart Failure With Milton Packer And Richard Lehman (Part 2) This is the second installment of an ongoing discussion about heart failure between Milton Packer, who has been leading major heart failure clinical trials for decades, and Richard Lehman, a retired UK GP who writes a blog for the BMJ website. (Click…
Dissecting The Press Release For A Failed Stem Cell Trial
–Stem cell therapy supporters can’t acknowledge that it might not work. Stem cells have never been shown to have any clinical benefit in patients with heart disease. But there is mounting anecdotal evidence that they may have serious adverse effects on the reasoning and objectivity of the medical researchers, biotechnology executives and investors who get…
End of the Road for CETP Inhibitors?
With the publication of the ACCELERATE trial in the New England Journal of Medicine the long train of bad and disappointing news for the once-promising approach of CETP inhibition remains unbroken. More than 12,000 high-risk patients were randomized in ACCELERATE to evacetrapib or placebo. In 2015 the trial was prematurely terminated for futility; the main…
A Conversation About Heart Failure With Milton Packer And Richard Lehman
Milton Packer and Richard Lehman are both 66 years of age. Packer has been leading major heart failure clinical trials for decades. Lehman is a retired UK GP who writes a blog for the BMJ website. The two have agreed to answer questions and participate in a discussion about their different ideas and perspectives about…
Study Fuels Debate Over When to Start Cholesterol Screening
–For younger adults, study finds low yield of 10-year risk-based screening A new study provides ammunition to supporters of a conservative approach to initiating cholesterol tests in younger adults. But proponents of a more aggressive approach argue that the interpretation does not take into account the enormous burden of cardiovascular disease as people grow older….
Recent Blow Ups Spark Call For Overhaul Of Clinical Trials
[Updated] –Trial leaders say they need to get down into the weeds of trial details. Large international trials are under fire. In recent weeks, as I’ve reported, serious questions have been raised about three major heart failure trials. There is no reason to believe these are the only trials about which questions will be raised…
Another Acute Heart Failure Drug Fails In Large Clinical Trial
–In RELAX-AHF-2 serelaxin didn’t improve clinical outcomes. Yet another promising drug for acute heart failure has failed to improve long-term outcomes. In the RELAX-AHF-2 trial 6,600 patients hospitalized for acute heart failure were randomized to a 48-hour infusion of serelaxin or placebo. There was no significant difference between the two groups in either of the…
Rigorous Study Debunks Alarms That Statins Cause Muscle Problems
(Updated, May 2, May 4) –The authors say muscle problems with statins are an example of the ‘nocebo’ effect. A new study helps debunk the widespread belief that statins cause muscle-related pain and weakness in large numbers of patients. The “nocebo effect” may be the cause of the epidemic of muscle pain among statin users,…
As Another Trial Goes Bust Investigators Call For Major Changes In International Trials
–Why were so many ineligible patients in Eastern Europe enrolled in TRUE-AHF? A new analysis of the recent TRUE-AHF trial offers strong evidence that large numbers of patients from Eastern Europe were ineligible for the trial and should not have been enrolled. The analysis doesn’t change the main finding of the trial, but it does…
Serious Questions Raised About Integrity Of International Trials
–TOPCAT analysis is the ‘smoking gun’ for trouble from ‘offshoring’ trials. Large international randomized controlled trials, the cornerstone of modern medicine, are in big trouble. As clinical trials have become a global enterprise, many observers have become increasingly worried about the integrity of data from certain geographic areas, in particular from Russia and other countries…
Principal Investigator Defends SPRINT Against Critics
–Blood pressure experts disagree about the NIH ‘Landmark’ Trial. Since the first announcement of its preliminary results the SPRINT trial has been the focus of intense controversy. One major focus of contention revolves around the precise technique used to measure blood pressure in the trial. As in all recent large outcome trials in hypertension, blood…
Concerns Over New Cardiac Blood Test Spark Intense Twitter Discussion
–Cardiologists fear the new high sensitivity troponin test will lead to lots of unnecessary testing. Along with many other cardiologists, Sek Kathiresan (Massachusetts General Hospital and Broad Institute) is worried that a new and improved diagnostic test will have disastrous unintended effects. Kathiresan expressed his concern on Twitter yesterday in response to my summary of a…
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